# K100890: Varian High Energy Linear Accelerator

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems
- Decided: Jul 13, 2010 after 104 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K913119 (1991). 8 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081188: Trilogy with External System Gating Interface, Varian Medical Systems, Inc. (2008) Summary page 1.
- K072916: Trilogy System with Rapidarc, Varian Medical Systems, Inc. (2007) Summary page 1.

## Most influential descendants
- K112839: Varian High Energy Linear Accelerator (2011), 3 descendants of its own
- K131807: High Energy Linear Accelerator (2013), 2 descendants of its own
- K162476: Varian High Energy Linear Accelerator (2016), 1 descendant of its own
- K181404: Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator (2018), 0 descendants of its own

## Recalls of this device
- Sep 9, 2011 · Not classified · Z-0181-2012: Varian has received reports in which a user has remotely rotated the gantry into contact with the couch or with the patient, in both the manual mode and the automate mode.
- May 31, 2011 · Class II · Z-1325-2013: Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interlock occurs. At maximum 
- May 26, 2011 · Not classified · Z-2978-2011: On Varian Linear Accelerators where the customer may calibrate the collimator angle position readout in reverse, switching the 90 degree and 270 degree positions.
- May 24, 2011 · Not classified · Z-2893-2011: The throat cover on the High Energy Clinac may detach if not properly installed and possibly strike a patient.
- May 18, 2011 · Not classified · Z-2764-2011: The Coolant System input water supply manifold may leak in some Clinac Linear Accelerators, posing a risk of electrical shock to any person working within the protective housing.
- May 13, 2011 · Not classified · Z-2778-2011: Some drive stand bolts may fail to meet mechanical specifications.
- Mar 31, 2011 · Not classified · Z-2224-2011: The coolant may leak. The resulting coolant leak presents a risk of electrical shock to any person working within the protective housing.
- Mar 28, 2011 · Not classified · Z-2195-2011: Varian has identified an anomaly whereby, following prolonged use, the screw fastener holding the wedge body to the tray may fail.
- Mar 17, 2011 · Not classified · Z-3204-2011: An improperly installed collimator cover may detach and fall from the machine, potentially striking the patient or nearby personnel.
- Feb 24, 2011 · Not classified · Z-2046-2011: The wedge angle labeling on the wedge tray may not correctly match the wedge body. However, the wedge body is labeled with the correct wedge angle.
- Dec 10, 2010 · Not classified · Z-1045-2011: An anomaly was identified whereby the bolts used to fasten the counterweight to the gantry may not, in some cases, be fully tightened to the required torque specification.

## Indications for use
The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Source page: https://510kreport.com/device/K100890
Methodology: https://510kreport.com/methodology